System and method for reshaping right heart

ABSTRACT

The present teachings provide devices and methods of reshaping the right heart and reducing tricuspid valve regurgitation. Specifically, one aspect of the present teachings provides an inflatable device to be deployed in the space between the sternum and the right heart. An injectable medium is injected to the cavity of the device. Once the device is filled, the device is detached from the delivery system, and released inside the body. The inflated device exerts pressure to the right heart, changes the shape of the tricuspid annulus, and allows a better coaptation of the tricuspid leaflets.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. patent application Ser.No. 62/272,882, filed Dec. 30, 2015, which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

The present teachings generally relate to an inflatable device, and itsuse in reshaping the right heart, reducing tricuspid regurgitations,or/and delaying progression of heart failure due to tricuspidregurgitation.

BACKGROUND

Tricuspid valve diseases relate to conditions in which the valve betweenthe two right heart chambers (i.e., the right ventricle and the rightatrium) doesn't function properly and these diseases often occur withother heart valve problems. Examples of the tricuspid valve diseasesinclude tricuspid valve regurgitation, tricuspid valve stenosis,tricuspid valve atresia, and the Ebstein's anomaly. In the tricuspidvalve regurgitation, the tricuspid valve doesn't close properly andblood flows back into the right atrium; in the tricuspid valve stenosis,the tricuspid valve is narrowed and reduces the amount of blood flowinginto the right ventricle; in the tricuspid atresia, a congenital heartdisease, a solid wall of tissues blocks the blood from flowing betweenthe two right heart chambers; and in the Ebstein's anomaly, a malformedtricuspid valve situates at a position lower than the normal position inthe right ventricle and causes blood to flow back into the right atrium.There are other tricuspid valve diseases generally known to a personwith ordinary skill in the art and these tricuspid valve diseases arealso included in the present teachings.

A tricuspid valve disease can be corrected by an annuloplasty ring. Insome instances, this device is preferred for surgically repairing adefective tricuspid valve. An annuloplasty ring is ananatomically-correct three-dimensional (3D) ring and can flexiblyconform to the heart valve opening. This ring is implanted into adefective tricuspid valve and reduces the valve opening. Properlyimplanted, an annuloplasty ring allows the valve to open and closeproperly.

Tricuspid valve repair surgeries can be done in one of the following twoways: a minimally invasive surgery or an open-heart surgery. A minimallyinvasive method involves making a small incision in the upper or lowerchest and inserting a valve repairing system/device percutaneously.After the valve is repaired, the incision is closed with dissolvingsutures. Comparing to an open-heart surgery, advantages of a minimallyinvasive approach include a shorter recovery time, less post-operationpain, and earlier return to work and normal daily activities.

However, there are drawbacks in valve replacement therapies and, as aresult, needs exist for repairing a diseased tricuspid valvepercutaneously.

SUMMARY

One aspect of the present teachings provides a device configured to bepositioned against a right heart. The device has a collapsed deliveryprofile and an inflated deployment profile. The flexible outer layer isconfigured to prevent moisture and gas from crossing the flexible outerlayer. The device comprises a flexible outer layer encasing a cavity.The cavity is configured to be filled with an injection medium. Thedevice further includes an injection port configured to be used to allowthe injection medium enter into the cavity.

In one embodiment, the device has a portion of the flexible outer layerwhich inflates to a greater extent than the rest of the flexible outerlayer.

In another embodiment, the flexible outer layer further comprises afirst component and a second component, wherein the first component andthe second component are binding together to form a waist. The firstcomponent is configured to be positioned against the right atrium. Thesecond component is configured to be positioned against a rightventricle. The waist is configured to be positioned outside of thetricuspid annulus. In its deployed configuration, the waist of theflexible outer layer inflates to a less extent than the first and secondcomponents.

Another aspect of the present teachings provides a device configured tobe positioned against a right heart, wherein the device has a collapseddelivery profile and an inflated deployment profile. The devicecomprises a flexible outer layer encasing a primary cavity and asecondary cavity radially outside of the primary cavity. The primarycavity is configured to be filled with an injection medium. Thesecondary cavity is configured to be filled with tissue bindingadhesives. A barrier separates the primary and second cavities,preventing moisture and gas from crossing the barrier. And a portion ofthe flexible outer layer outside of the secondary cavity has a pluralityof pores, allowing the tissue binding adhesive to exit the secondarycavity to the outside of the flexible outer layer.

In one embodiment, when filled with injection medium, the barrierseparating the primary and second cavities expands to a greater extentthan the portion of the flexible outer layer outside of the secondarycavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of the present teachingswhere an inflatable balloon is positioned against the right heart freewall according to the present teachings.

FIG. 2 is a perspective view of an embodiment of the present teachingswhere a needle is used to puncture subxiphoid to access the treatmentspace according to the present teachings.

FIG. 3 is an embodiment of the inflatable balloon in its deliveryprofile and attached to a delivery system in accordance with the presentteachings.

FIG. 4 is an embodiment of the inflatable balloon positioned against theright heart free wall according to the present teachings.

FIG. 5 is an embodiment of the inflatable balloon in its deliveryprofile according to the present teachings.

FIG. 6 is an embodiment of the inflatable balloon in its deliveryprofile according to the present teachings.

FIG. 7 is an embodiment of the inflatable balloon in its deliveryprofile according to the present teachings.

FIG. 8 is an embodiment of the inflatable balloon attached to a deliverysystem in accordance with the present teachings.

FIG. 9 is an embodiment of the inflatable balloon disengaging from adelivery system in accordance with the present teachings.

FIG. 10 is a perspective view of an embodiment of the present teachingswhere an inflatable balloon is delivered to the treatment location via adelivery system.

FIG. 11 is a perspective view of an embodiment of the present teachingswhere an inflatable balloon is deployed at the treatment location via adelivery system.

FIG. 12 is a perspective view of an embodiment of the present teachingswhere an inflatable balloon is deployed at the treatment location via adelivery system.

DETAILED DESCRIPTION

Certain specific details are set forth in the following description andfigures to provide an understanding of various embodiments of thepresent teachings. Those of ordinary skill in the relevant art wouldunderstand that they can practice other embodiments of the presentteachings without one or more of the details described herein. Thus, itis not the intention of the Applicant(s) to restrict or in any way limitthe scope of the appended claims to such details. While variousprocesses are described with reference to steps and sequences in thefollowing disclosure, the steps and sequences of steps should not betaken as required to practice all embodiments of the present teachings.

As used herein, the term “lumen” means a canal, a duct, or a generallytubular space or cavity in the body of a subject, including a vein, anartery, a blood vessel, a capillary, an intestine, and the like. Theterm “lumen” can also refer to a tubular space in a catheter, a sheath,a hollow needle, a tube, or the like.

As used herein, the term “proximal” shall mean close to the operator(less into the body) and “distal” shall mean away from the operator(further into the body). In positioning a medical device inside apatient, “distal” refers to the direction away from a catheter insertionlocation and “proximal” refers to the direction close to the insertionlocation.

As used herein, the term “wire” can be a strand, a cord, a fiber, ayarn, a filament, a cable, a thread, or the like, and these terms may beused interchangeably.

As used herein, the term “sheath” may also be described as a “catheter”and, thus, these terms can be used interchangeably.

Unless otherwise specified, all numbers expressing quantities,measurements, and other properties or parameters used in thespecification and claims are to be understood as being modified in allinstances by the term “about.” Accordingly, unless otherwise indicated,it should be understood that the numerical parameters set forth in thefollowing specification and attached claims are approximations. At thevery least and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the attached claims, numericalparameters should be read in light of the number of reported significantdigits and the application of ordinary rounding techniques.

The present teachings relate to devices and methods for treating atricuspid valve regurgitation percutaneously. A person with ordinaryskill in the art would recognize that the figures and descriptionthereto refer to various embodiments of the present teachings and,unless indicated otherwise by their contexts, do not limit the scope ofthe attached claims.

An aspect of the present teachings relates to methods of reducing thesize of the right heart, and subsequently reducing the tricuspidregurgitation. In various embodiments, the method includes deploying aballoon (10) through a percutaneous subxiphoid approach to the outsideof the pericardium (2) as illustrated in FIG. 1. The balloon (10)squeezes the right side of the heart, both the right atrium (RA) and theright ventricle (RV). As a consequence, the tricuspid annulus changes itshape, which leads to more coaptation among the leaflets of thetricuspid valve (5).

In various embodiments, the balloon is positioned inside or outside ofthe pericardium. In various embodiments, the balloon is positionedapproximately to the anterior and posterior commissure with a smallportion, such as 30%, against the right atrium and a relatively largerportion against the right ventricle. In various embodiments, the balloonis anchored to the sternum. In various embodiments, the balloon isshaped to be self-anchoring, self-aligning, or self-stabilizing. In someembodiments, the balloon in its deployed configuration includes anindentation. In certain embodiments, the indentation is in a shape ofwedge. In certain embodiments, the indentation is configured to fit theheart into the wedge when the balloon is in its deployed configuration.In particular embodiments, the wedge pushes posteriorly on the anteriorportion of the right heart. In particular embodiments, the balloon isstabilized between the heart and the sternum by the wedge cupping withthe right heart.

FIG. 2 illustrates insertion of a needle (8) to the space between theheart and the sternum. According to some embodiments of the presentteachings, the access to the space is done through a subxiphoidapproach. The procedure starts with a small vertical incision to theleft of the subxiphoid. A puncture through the skin and subcutaneoustissue is made straight or at a 45-degree angle pointing toward theright shoulder. One skilled in the art should understand that thepuncture is done by using a Tuohy needle, with appropriate endocardialand/or fluoroscopy guidance. Additionally contrasts should be used toascertain the puncture location.

In various embodiments, access for an insertion catheter is createdthrough a needle and wire exchange. In some embodiments, a needle isused to puncture the chest cavity starting from below the xiphoidprocess and angling the needle superior and left. In some embodiments, aneedle is used to puncture the chest cavity through the 5th or 6thintercostal space on the left side of the sternum. In some embodiments,once a needle is passed through the sternum, a wire is advanced throughthe needle into the space between the sternum and the pericardial sac.In various embodiments, the wire is specially designed to help removeany adhesions between the pericardium and the sternum. In someembodiments, the wire is left behind and the needle is removed. Invarious embodiments, an insertion catheter is advanced over the wire andinto the target region of the anatomy. In some embodiments, theinsertion catheter includes a dilating sheath or dilating tip designedto increase the diameter of the needle hole. In some embodiments, aseparate dilating member is used prior to insertion of the catheter. Insome embodiments, a fluid is injected into the target space of theanatomy in order to facilitate the subsequent inflation of the bladder.In some embodiments, the fluid is saline or nitrogen gas. In someembodiments, the fluid includes a biocompatible, bio-resorbablelubricant.

In various embodiments, access for an insertion catheter is accomplishedthrough a novel modification of a pericardiocentesis kit. In someembodiments, a needle is advanced through the sternum and through thepericardium as is commonly done to aspirate effusions from thepericardium. In some embodiments, a wire is advanced through the needleand into the pericardial space and the needle is retracted out of thebody. In some embodiments, an access catheter is advanced over the wire.In various embodiments, the access catheter is designed with a bluntedtip such that it passes through the sternum but does not dilate the holein the pericardium created by the needle. In some embodiments, theaccess catheter is advanced through the sternum and up to but notthrough the pericardium. In some embodiments, the wire is withdrawn andthe catheter is repositioned in order to deliver the balloon.

In various embodiments, the delivery of the access catheter is aided byfluoroscopy, transesophageal echocardiography, or transthoracicechocardiography. In some embodiments, the delivery catheter or deliverysystem includes piezo electric elements designed to function as aspecially designed echo probe. In some embodiments, the access catheterdelivery system is designed to engage a separate and commerciallyavailable TTE probe for imaging assistance during the procedure.

In various embodiments, the access to the space between the pericardiumand the heart chambers is facilitated by an indwelling catheter in theright heart. In some embodiments, the right heart catheter is designedto create a small puncture in the right atrial appendage. In someembodiments, the right heart catheter is used to inject a predeterminedamount of saline or other fluid into the pericardial space. In someembodiments, the fluid is echogenic. In some embodiments, the fluid isused to create separation between the right heart and the pericardium.In some embodiments, the fluid is injected into the pericardium and thenaspirated back through the access catheter or through the right heartcatheter. In some embodiments, a space is created between thepericardium and the right heart by a right heart catheter. In certainembodiments, the right heart catheter is designed to grasp a portion ofthe right heart, for example, the right atrial appendage, or theanterior wall of the right atrium. In some embodiments, the right heartcatheter is designed to grasp the anterior wall of the right heart abovethe plane of the right coronary artery. In certain embodiments, theright heart catheter is retracted by 2-3 cm in order to create somespace between the pericardium and the right heart.

In various embodiments, the distal end of the insertion needle (8) ispositioned outside of the pericardium. In other embodiments, the distalend of the insertion needle (8) is further advanced slightly to puncturethe pericardium and reach inside the pericardial space.

Another aspect of the present teachings provides an inflatable balloon(10) that can be deployed at a treatment location, as shown in FIG. 4.In various embodiments, the inflatable balloon (10) has a cavity (37)(FIG. 5) encased by at least one layer of a flexible material. In someembodiments, the inflatable balloon (10) has a delivery state where itis housed and delivered through a delivery system (20) as shown in FIG.3. In one embodiment, the delivery system (20) includes an access sheath(22), a delivery catheter (24), and an injection catheter (26). In someembodiments, the inflatable balloon (10) has a deployed state, where itis filled with an injectable medium, such as a liquid, a gel, a gas,foam, or another medium. In some embodiments, the delivery state of theinflate balloon (10) is referred to as a state where the device iscompletely free of injectable medium. Alternatively, in someembodiments, the balloon (10) is partially filled with some injectablemedium. In some embodiments, any state that is greater in size than thedelivery state is considered to be a deployed state.

In various embodiments, as shown in FIG. 4, at its deployed state, theballoon (10) is positioned against the right heart anterior free wallapproximate to the outside of the tricuspid valve (5) annulus location(See, FIG. 1). As shown in FIG. 4, a portion of the balloon (10) isplaced and compresses against the right atrium, and another portion ofthe balloon (10) is placed and compresses against the right ventricle.In some embodiments, the balloon (10) at its deployed state isconfigured to compress the right side of the heart, changes the profileof the tricuspid annulus, and, as a result, improves the coaptation ofthe tricuspid leaflets and reduces tricuspid regurgitation. One skilledin the art should understand that the deployed state of the balloon (10)could vary from a patient to another patient due to the individualanatomy and the amount of compression needed to achieve a reduction intricuspid regurgitation. Thus, the amount of the medium injected insidethe cavity (37) of the inflatable balloon (10) is determined based oneach patient's needs and controlled by a clinician.

According to some embodiments, the medium filled inside the cavity (37)of the balloon (10) could be an injectable medium, such as a liquid, ahydrogel, a gas, or foam. In an embodiment, other materials orstructures, that is capable of maintaining its volume as well aschanging its shape to conform to the anatomic space at the implantinglocation while under compression, could also be used. In anotherembodiment, the injectable medium is capable of reducing its volumewhile under compression, and increasing its volume after the compressionis removed, for example, a material capable of undergoing a phase changefrom a first volume to a second volume at the temperature and/orpressure ranges inside a body cavity (37) may also be used.

Now referring to FIG. 5, where an exemplary embodiment of an inflatableballoon (30) is illustrated in its deployed profile. In variousembodiments, the inflatable balloon (30) comprises a flexible wall (32)and an injection port (34). In various embodiments, the flexible wall(32) is configured to transfer the pressure from the inside to theoutside of the balloon (10). As a result, in some embodiments, theinflatable balloon (10) exerts a force to the heart. In variousembodiments, the flexible wall (32) is flexible. In some embodiments,the flexible wall (32) allows shape change of the balloon (30) while theballoon (30) is exposed to an external pressure from the anatomy. Invarious embodiments, the flexible wall (32) is stiff enough to hold thepressure exerted by the medium inside the balloon (30).

Continue referring to FIG. 5, according to some embodiments, theinjection port (34) joins, releasably, a medium injection catheter (26)(See, FIG. 3). As later described, in some embodiments, once joined, theinjection catheter (26) is configured to push, pull, or otherwisemanipulate the inflatable balloon (30). In some embodiments, theinjection catheter (26) is configured to deliver a medium into thecavity (37) of the balloon (30).

According to some embodiments, the flexible wall (32) of the devicecomprises at least one gas barrier layer. According to some embodiments,the flexible wall (32) comprises at least one moisture barrier layer.According to some embodiments, the gas barrier layer and moisturebarrier layer are laminated together. In some embodiments, the gasbarrier is constructed as an external layer of the flexible wall (32).In some embodiments, the moisture barrier is constructed as an internallayer of the flexible wall (32). In other embodiments, the moisturebarrier is constructed as an external layer of the flexible wall (32).In other embodiments, the gas barrier is constructed as an internallayer of the flexible wall (32). In other embodiments, the gas barriermaterial and moisture barrier material are blended together to form asingle barrier layer. Yet in other embodiments, more than one layer ofthe gas barrier and/or more than one layer of the moisture barrier layerare incorporated. In some embodiments, the more than one layer of thegas barrier and the more than one layer of the moisture barrier layerare arranged in an alternating manner. In yet other embodiments, anyother arrangements are equally applicable as long as they are suitablefor the purpose of the present teachings and their manufacturingcapability.

A variety of gas barrier materials, including polyvinylidene chloride,ethyl vinyl alcohol, fluoropolymers, or etc., can be used forconstructing a device of the present teachings. Gas barrier materialsare generally relatively stiff, have high moisture vapor permeability,and low impact strength. Consequently, a layer of flexible material withhigh moisture barrier and high impact strength should also beincorporated into the flexible wall (32) of the device.

A variety of moisture barrier materials, including polyamide,polyethylene, polypropylene, polyurethane, polyamide/polyestercopolymer, polystyrene/polybutadiene copolymer, and etc., can be usedfor constructing a device of the present teachings. The moisture barriermaterials are generally flexible and have high impact strength.

In some embodiments, an additional reinforcement layer is incorporatedinto the flexible wall (32) in order to enhance the structural integrityof the device. In some embodiments, the reinforcement layer has highimpact strength. In certain embodiments, the reinforcement layer is madeof a polymer, including polyurethane, EVA, PE, polypropylene, orsilicone. In various embodiments, the reinforcement layer is an externallayer of the flexible wall (32). In various embodiments, thereinforcement layer is an internal layer of the flexible wall (32). Invarious embodiments, the reinforcement layer is a middle layer of theflexible wall (32). In some embodiments, the flexible wall (32) includesmore than one reinforcement layer. In certain embodiments, at least oneof the more than one reinforcement layers is between a gas barrier layerand a moisture barrier layer.

In some embodiments, the device have three, four, five, or more layersincluding a gas barrier layer, a moisture barrier layer, and one or morereinforcement layers. In some embodiments, the device has multiple gasbarrier layers and/or multiple moisture barrier layers, arranged in asequential or non-sequential arrangement.

In various embodiments, the overall thickness of the flexible wall (32)is preferably minimized. In some embodiments, the overall thickness ofthe flexible wall (32) ranges between 0.003 to 0.03 inches. In someembodiments, each layer of the flexible wall (32) has a same thickness.In some embodiments, at least two layers have different thickness. Incertain embodiments, each layer of the flexible wall (32) has adifferent thickness from the other layers.

The layers of the flexible wall (32) can be made in any number of waysknown to those skilled in the art, including, but not limited to,lamination, co-extrusion, dip molding, spray molding, or the like. Invarious embodiments, the flexible wall (32) is made by laminating two ormore layers together. Lamination can be achieved through many techniquesknown to those skilled in art. In some embodiments, the lamination isachieved by using heating, solvents, adhesives, tie layers, or otherlike methods.

One skill in the art would understand that the material used toconstruct the flexible wall (32) of the device is sufficiently flexiblein the thickness ranges selected for the present teachings. Since thedevice is subject to external pressures, the device's material invarious embodiments is able to transmit the pressure from the sternum tothe right heart. In various embodiments, the material used to constructthe flexible wall (32) is selected to produce an appropriate compressionto the right heart. In various embodiments, the pressure and volume ofthe inflation medium (injection medium) is selected to produce anappropriate compression to the right heart. For example, in its deployedprofile, the device is sufficiently stiff to compress the right heart.In some embodiments, the compression leads to a change of the profile ofthe tricuspid annulus. In some embodiments, the device is flexibleenough to accommodate the right heart expansion during the diastoliccycles.

According to some embodiments, the right heart pressure, such as theright ventricle pressure, is closely monitored during the balloonexpansion in order to prevent from over-pressuring the right heart. Forexample, during the balloon expansion, the pulmonary capillary wedgepressure (PCWP) can be monitored and the PCWP can sometimes serve as agood indicator for the right ventricle pressure. When it shows that theright ventricle is over pressured, for example, beyond 40 mmHg, aclinician can deflate the balloon.

According to some other embodiments of the present teachings, theballoon is designed in such way that after deployed, it can still bereattached to a catheter in order to further inflate or deflate theballoon to achieve the optimum treatment result. For example, a ballooncan include an injection port which can be reattached by an injectioncatheter after the procedure. In another example, a balloon can alsoinclude a lead which can be left behind and used to be re-attached forpressure adjustment after the procedure.

According to other embodiments of the present teachings, a pumpingmechanism between the components of the balloons is also incorporated inthe design in order to allow fluid transfer between the components. Insome embodiments, such pumping mechanism allows pressure adjustment ineach component of the balloon and can be used to avoid over pressuringcertain part of the heart, or create a messaging effect to the heart.

In some embodiments, the flexible wall (32) comprises a continuous layerof material. In some embodiments, such as FIG. 6, the flexible wall (42)comprises a first component and a second component, where the first andsecond components are bonded together. Once injected with the medium,the first component and second component of the balloon (40) expands,while the bonding seam between the first component and second component,remains unchanged, or only slightly stretched, forming a waist in itsdeployed profiled, such as shown in FIG. 6. In some embodiments, thebonding seam is configured to be positioned outside of the tricuspidvalve (5) annulus.

One skilled in the art should understand that the two components can beidentical or different in sizes. In some embodiments, the components tobe deployed against the right ventricle are larger than the component tobe deployed against right atrium. According to some embodiments, theseams are accomplished in any of a variety of manners known to thoseskilled in the art. In certain embodiments, the bonding of the twocomponents are achieved by using heat bonding, chemical bonding,mechanism bonding, and the like. One skilled the art should understandthat more than two components can be included in forming the device.Thus, the embodiments disclosed herein should not be viewed as limiting.

According to some embodiments, once injected with a medium of thepresent teachings, the balloon (10) device as illustrated in FIGS. 5-6expand evenly in all directions. In other embodiments, the expansion ofthe balloon (10) is controlled with the most expansion inwardly towardthe heart, and less or no expansion in other directions so that oncedeployed, the portion of the balloon (10) facing the heart wall expandsand compresses the right heart.

According to some embodiments of the present teachings, the balloon isexpanded in a sequential motion with one component expanding afteranother. In other embodiments of the present teachings, the balloonexpansion is controlled by a dynamic pulse control, such that onecomponent is expanded with a long pulse, and another component isexpanded with a high pulse. One skilled in the art should understandthat balloon expansion can be achieved by many other ways, and theexemplary approaches described herein should not be viewed as limitingto the scope of the present teachings.

In some embodiments, once inflated, the balloon (10) has an overallwidth of 2 mm-4 cm and an overall height of 4 mm-6 cm. In someembodiments, the portion of the balloon (10) against the right ventricleis greater than the portion of the balloon (10) against the rightatrium.

In various embodiments, the balloon is designed to be compliant only upto a predetermined size and shape. After the balloon is inflated to thisshape by the injectable fluid, the balloon resists further inflation. Insome embodiments, the resistance to additional inflation is accomplishedby the composite construction of the balloon. In some embodiments, thewall of the balloon includes fibrous members such as suture material,braided polyester fibers, nylon strands, or other materials. In someembodiments, the bladder is loosely defined as a non-compliant balloon.In some embodiments, the bladder is designed to inflate in a stepwisemanner. In various embodiments, in the first step, the bladder isdesigned to expand in a manner that is largely flat, expanding along thecontact surface of the right heart and the sternum. In some embodiments,as the inflation pressure increases and the largely flat expansion ofthe balloon nears its final size, the balloon expands largely byincreasing in thickness. In some embodiments, the balloon includes twofluid sealed cavities/chambers. In some embodiments, the firstcavity/chamber includes a large flat shape which contours to the wall ofthe sternum and to the shape of the heart. In some embodiments, thesecond cavity/chamber is designed to expand largely in the thicknessdimension, thereby pushing against the sternum and the heart but notexpanding in other directions.

According to various embodiments (e.g., FIG. 5), the injection port (34)of the device includes an injection tube (36) and a valve (38). Theinjection tube (36) creates a fluid communication path between theinterior cavity (37) and the injection catheter (26). The valve (38) isconfigured to permit one way flow through the injection tube (36). Uponremoval of the injection catheter (26), the valve (38) closesautomatically and prevents the escape of the injection medium from theinterior cavity (37) through the injection tube (36).

According to some embodiments, the injection tube (36) has a connectedend joining to the flexible wall (32) and a free end (35) extending intothe cavity (37) of the balloon (10). In certain embodiments, the tubeincludes a tubular lumen (33) extending from the connected end to itsfree end (35). The tubular lumen (33) forms a flow path for theinjection medium to be delivered inside the cavity (37) of the balloon(10). In other embodiments, the valve (38) is positioned inside thetubular lumen (33) of the Tube. Although FIG. 5 illustrates a valve (38)in the middle portion of the tubular lumen (33), one skilled in the artwould understand that the valve (38) can be at or near the connected endof the injection tube (36), at or near the free end (35) of theinjection tube (36), or anywhere inside the lumen between the connectedand free end (35) of the injection tube (36).

According to various embodiments, the injection tube (36) is made ofpolyethylene, Pebax, polyurethane, etc. In various embodiments, theinjection tube (36) is made by a known technique in the field. In someembodiments, the injection tube (36) is made by extrusion. According tovarious embodiments, the valve (38) and flap are made from a flexiblematerial such as polyurethane, silicone, or polyethylene. According tosome embodiments, the bonding between the valve (38) and tube, the tubeand the flexible wall (32) of the balloon (30), and the flap and thetube is achieved by a known technique in the field. In certainembodiments, the bonding is achieved through a mechanical means. Inparticular embodiments, the bonding is through a screw, a bolt, a clamp,or the like. In certain embodiments, the bonding is achieved through achemical means. In particular embodiments, the bonding is achievedthrough an adhesive or the like. In some embodiments, the bonding isachieved through a thermal means. In particular embodiments, the bondingis achieved by ultrasonic welding, laser welding, overmolding, or thelike. Other attachment methods known to the skilled artisan can also beused.

According to various embodiments of the present teachings, upon thedevice being filled with the medium content, the device resumes apredesigned deployed profile. In some embodiments, upon inflation, thedevice assumes a general spherical profile, a pillow profile, or a snowman profile with a waist. One skilled in the art should understand thatan inflated device can assume any profile that is suitable for itsintended function.

According to various embodiments, the valve (38) inside the injectiontube (36) has a duckbill configuration. In some embodiments, the valve(38) includes a first and a second duck bill valve (38) leaflets whichare attached to the tubular wall. In some embodiments, the leafletsextend in the direction toward the free end (35) of the injection tube(36) and form a pair of coaptive edges. This configuration allows adistal-direction flow to separate the coaptive edges, thereby enablinginflation of the device. Upon removal of the injection medium source,the inflation medium within the device in combination with the naturalbias of the leaflets cause the leaflets to coapt, thereby preventing anyproximal flow of medium through the flow path. One skilled in the artshould understand that other suitable valve (38) design, such astricuspid, flap, biased valve (38), known in the field could also beused here. Thus, the embodiments disclosed herein should not be viewedas limiting to the overall scope of the present teachings.

FIG. 7 illustrates another embodiment of the present teachings, wherethe balloon (50) further includes a binding mechanism that is configuredto secure a deployed balloon (50) at a treatment location. As shown inthe figure, the inflatable balloon (50) has two cavities. The primarycavity (54) is configured to be filled with an inject medium whichcauses the balloon (50) to expand. The secondary cavity (52) isconfigured to contain a bio-adhesive. And the secondary cavity (52) islocated radially outside of the primary cavity (54) as shown. Accordingto one embodiment, the secondary cavity (52) is located radially outsideof the primary cavity (54). A barrier (56) exists between the primaryand secondary cavities (52), which prevents the injection medium fromexiting the primary cavity (54) and entering the secondary cavity (52).According to some embodiments, the secondary cavity (52) is covered withan external stretchable and porous layer (58). Similar to the previousembodiments, the balloon (50) includes an injection port (64), aninjection tube (36) and a valve (68) disposed within the injection tube(36).

When the balloon (50) is in its delivery collapsed profile, the adhesiveis stored inside the secondary cavity (52). The delivery system carriesthe collapsed balloon (50) into the treatment location. Once the balloon(50) is filled with injection medium, as the balloon (50) expands, theexternal porous layer (58) outside of the secondary cavity (52) alsostretches, allowing the pores to be opened up. As the balloon (50)further expands, it squeezes the adhesive, letting it exit the pores(62). The adhesive is configured to bond the balloon (50) with thesternum.

In some embodiments, when filled with the injection medium, the barrier(56) separating the primary and second cavities (54, 52) expands morethan the portion of the flexible outer wall outside of the secondarycavity (52). As a result, the difference in stretchability would allowthe primary cavity (54) to expand at a greater rate than the secondarycavity, thereby pushing the tissue binding adhesive out of the pores(62) in the flexible wall (58).

In some embodiments, the balloon (50) is designed such that undercertain inflation pressures, the adhesive remains inside the secondarycavity (52). Once a clinician is satisfied with the deployment and/orapposition, the balloon (50) is inflated to a final pressure and theadhesive is then pushed out to the external surface (58). In someembodiments, the adhesive is activated upon being exposed to themoisture of the anatomy.

According to one embodiment of the present teachings, the secondarycavity is configured to be positioned approximately to the rightventricle, so that after an adhesive is applied to the exterior surface,the balloon is bonded to the right ventricle. In another embodiment, thesecondary cavity is configured to be positioned approximately to theright atrium, so that the adhesive is used to bond the balloon to theright atrium of the heart.

FIG. 8 further illustrates a balloon delivery system configured to jointhe balloon (40) at its injection port (44). In various embodiments, theballoon delivery system controls the movement of the balloon (40) andinjects the inflation medium into the cavity (47) of the inflatableballoon (40). According to some embodiments, the balloon delivery systemcomprises an elongate delivery catheter (24) having a proximal end and adistal end. The delivery catheter (24) is configured to slide through anaccess sheath (22) (not shown) placed at the treatment location. Thus,the delivery catheter (24) preferably has an outside diameter of no morethan about 8 mm. The length of the delivery catheter (24) may vary,depending upon each patient. In general, an axial length of deliverycatheter (24) is within the range of from about 1″ to about 10″ foradult patients.

According to various embodiments, the delivery catheter (24) has acentral lumen extending axially therethrough. The central lumen axiallyslideably receives an injection catheter (26) for filling the balloon(40). The injection catheter (26) comprises a tubular body having aproximal end, a distal end, and a medium injection lumen extendingthroughout the length from its distal end to a proximal hub where aconnector is typically used for coupling the proximal hub to a source ofinflation medium.

According to various embodiments, the injection catheter (26) extendsdistally, or retracts proximally, independent of the delivery catheter(24). The distal end of the injection catheter (26) has a generallytubular shape and is configured to be positioned within the valve (48)inside the injection port (44) of the balloon (40). The distal end ofthe delivery catheter (24) is dimensioned such that it fits through theinjection port (44) of the balloon (40). In some embodiments, thedelivery catheter (24) further includes a distal stop surface configuredto stop the proximal movement of the device as shown in FIG. 8.

FIG. 8 illustrates an embodiment of the present teachings where theballoon delivery system is fully engaged with the balloon (40). Asillustrated, the distal end portion of the injection catheter (26) isfit inside the injection tube (46) and positioned across the valve (48).In some embodiments, the distal end portion of the injection catheter(26) is capable of opening the valve (48). The distal end of theinjection catheter (26) is within the injection tube (46) and distal tothe valve (48). The distal end of the delivery catheter (24) contactsthe proximal end of the injection tube (46). In some embodiments, theballoon (40) is pushed distally, retracted proximally, torqued radially,and otherwise manipulated by the balloon delivery system.

In various embodiments, the valve (48) inside the injection tube (46) ofthe balloon (40) has a mechanism that prevents the injection medium fromback-flowing to the outside of the balloon (10). According to someembodiments, once the injection catheter (26) is placed inside theinjection port (44), a clinician can inject the inflation medium intothe cavity (47) of the balloon (40).

After the balloon (40) is inflated to a desired size, a clinician invarious embodiments stops the medium injection and removes the injectioncatheter (26). As shown in FIG. 9, with the delivery catheter (24)remains steady, the injection catheter (26) can be withdrawn proximallyand exit the injection port (44) of the balloon (40). The one-way valve(48) inside the injection port (44) closes automatically and seals theinjection medium inside the balloon (40).

FIGS. 10-11 illustrate a deployment process of the balloon (10). Asshown in FIG. 10, an access sheath (22) is first placed at the treatmentlocation following a subxiphoid puncture described above. According tosome embodiments, the access sheath (22) is used to slideably carry theballoon delivery system assembly. In some embodiments, the balloondelivery system assembly slides from a proximal end of the access sheath(22) to its distal portion after proper placement of the access sheath(22). In some embodiments, during delivery, the deflated balloon (10) isrolled around a distal end portion of the injection catheter (26) andcarried within the tubular lumen of the access sheath (22) during theplacement.

As shown in FIG. 10, once the system is properly positioned, the accesssheath (22) is retracted proximally with respect to the balloon deliverysystem (20) in order to expose the deflated balloon (10). A medium isthen introduced distally from the proximal hub of the injection catheter(26) to inflate the balloon (10) to an intended degree.

Following the inflation of the balloon (10), as shown in FIG. 11, theinjection catheter (26) is disengaged from the injection port (34) ofthe balloon (10) by retracting the injection catheter (26) with respectto the delivery catheter (24). A distal stop surface on the deliverycatheter (24) prevents the proximal movement of the balloon (10) as theinjection catheter (26) is proximally retracted. The balloon deliverysystem (20) is thereafter removed from the patient, leaving the inflatedballoon (10) within the body.

In various embodiments, the balloon device expands in a step-wisefashion. In some embodiments, the balloon device expands to a firstlength. In some embodiments, the balloon device expands to a firstwidth. In some embodiments, the balloon expands to a first length firstand a first width second. In some embodiments, the balloon expands to afirst width first and a first length second. In certain embodiments, thefirst length is predetermined. In certain embodiments, the first lengthis adjustable according to the patient's need. For example, as shown inFIG. 12, the first length can be approximately the length of thepericardial cavity. In another example, as shown in FIG. 12, the widthcan be the width of the pericardial cavity. In some embodiments, thefirst width varies along the length of the balloon. As such, in certainembodiments, the balloon expands inwardly toward the right atrium. Incertain embodiments, the balloon expands inwardly toward the rightventricle. Although FIG. 12 shows a particular length and width of aballoon device, one with ordinary skill in the art would understand thatthe length or/and the width of the balloon device can be greater or lessthan what are shown in FIG. 12.

One skilled in the art should understand that the devices disclosedabove are merely embodiments of the present teachings. For example, theballoons illustrated in the drawings show only one injection port forinflation. One skilled in the art should understand that more than oneinjection ports can be incorporated in the balloon design withoutdeparting from the scope of the present teachings. In another example,the implantation of the balloon at a desired treatment site is donethrough a subxiphoid puncture procedure. An alternative to suchimplantation route can be to insert the balloon into the right atriumthrough a standard right heart catheterization procedure followed by apuncture to the heart wall from inside the right atrium. A furtheralternative can be to insert the balloon into the right atrium, then toextend through the tricuspid valve into the right ventricle, and finallyto puncture through the right ventricular wall. Other alternativeimplantation route(s) can also be incorporated, and all of which shouldbe considered as part of the present teachings.

The methods and devices disclosed above are useful for treating one ormore symptoms of tricuspid regurgitation, by reducing the right heartsize. One skilled in the art would further recognize that devicesaccording to the present teachings could be used to treat varioussymptoms of mitral regurgitation. For example, the devices disclosedherein can be deployed against the left heart.

Various embodiments have been illustrated and described herein by way ofexamples, and one of ordinary skill in the art would recognize thatvariations can be made without departing from the spirit and scope ofthe present teachings. The present teachings are capable of otherembodiments or of being practiced or carried out in various other ways.Also, it is to be understood that the phraseology and terminologyemployed herein is for the purpose of description and should not beregarded as limiting.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this present teachings belong. Methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present teachings. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and notintended to be limiting.

We claim:
 1. Apparatus comprising: a delivery system comprising: anaccess sheath, configured to be introduced to a treatment locationoutside a right side of a heart of a subject; a delivery catheter; andan inflation catheter; and a device configured to be positioned at thetreatment location, against the right side of the heart, the devicecomprising: a tissue-binding adhesive; a flexible outer layer encasing aprimary cavity and a secondary cavity outside of the primary cavity, aportion of the flexible outer layer outside of the secondary cavityhaving a plurality of pores between the secondary cavity and the outsideof the flexible outer layer; a barrier separating the primary andsecondary cavities, preventing moisture and gas from crossing thebarrier; and an injection port configured to allow an injection mediumto be introduced into the primary cavity, the injection port comprisingan injection tube that is disposed entirely within the primary cavityand is only in fluid communication with the primary cavity and not thesecondary cavity, the injection port being configured for beingdetachably coupled to the inflation catheter, wherein: the device has acollapsed delivery profile and an inflated deployment profile, in thecollapsed delivery profile, the device is dimensioned to be advanced,within the access sheath, to the treatment location, while the secondarycavity contains the tissue-binding adhesive, the device is inflatableinto the inflated deployment profile by introducing the injection mediuminto the primary cavity via the inflation catheter and the injectionport, and introducing the injection medium into the primary cavity viathe injection port squeezes the tissue-binding adhesive out of thesecondary cavity via the pores.
 2. The apparatus according to claim 1,wherein the barrier separating the primary and secondary cavitiesexpands more than the portion of the flexible outer layer outside of thesecondary cavity when the injection medium is introduced into theprimary cavity, thereby allowing the primary cavity to expand at agreater rate than the secondary cavity, thereby causing expulsion of thetissue-binding adhesive through the pores.
 3. The apparatus according toclaim 1, wherein the device further includes a one-way valve disposedwithin the injection tube.
 4. The apparatus according to claim 1,wherein the barrier extends longitudinally from a distal end to aproximal end of the device which is in the form of an inflatableballoon.
 5. The apparatus according to claim 1, wherein the secondarycavity is disposed alongside the primary cavity.
 6. The apparatusaccording to claim 1, wherein: the portion of the flexible outer layeris a first portion of the flexible outer layer that delineates at leastpart of the primary cavity, and a second portion of the flexible outerlayer delineates at least part of the secondary cavity.
 7. The apparatusaccording to claim 1, wherein the primary cavity is configured toinflate into a flat shape.